Endoplus 5 mm Traumatic Grasper Recalled for Broken Jaw
Endoplus is recalling 9 units of 5 mm Traumatic Graspers because the moveable jaw broke during laparoscopic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device failure during surgery, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Endoplus, Inc. is recalling 9 units of 5 mm Traumatic Graspers (REF 345VA, Lot F3). These non-sterile precision laparoscopic instruments are intended for grasping, dissecting, retraction, and clamping during laparoscopic surgery.
The recall was initiated due to multiple complaints reporting that the moveable jaw of the instrument broke during laparoscopic procedures. The affected units were distributed in the states of Florida, Texas, and Virginia.
Healthcare facilities and consumers should stop using the affected instruments immediately and contact Endoplus, Inc. for instructions on return or replacement.
The recalled product
- Product
- ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
- Manufacturer
- Endoplus, Inc.
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item: 345VA
- Lot Number: F3
Distribution
Part of a larger recall action
This product is one of 2 recalled by Endoplus, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Endoplus, Inc.
See all →- HighEndoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw
FDA (Devices) · 2013-10-02
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